Pronase Granules in Gastric Cleaning

February 21, 2022 updated by: Zhuan Liao, Changhai Hospital

The Efficiency of Pronase Granules in Gastric Cleaning of Magnetically Controlled Capsule Endoscopy: a Prospective Randomized Controlled Study

Magnetically controlled capsule endoscopy (MCE) is now widely used all over the world. However, the standard gastric preparation method by dimethicone we used clinically still has mucus at the bottom of the stomach. In this study, we aimed to determine whether pronase granules is helpful to improve the cleanliness of gastric mucosa in MCE.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

As a non-invasive and well-tolerated gastrointestinal examination method, magnetically controlled capsule endoscopy (MCE) is being increasingly used in different populations in recent years. Gastric preparation is extremely important for the completion rate (CR), image quality, and diagnostic efficiency because of the plica of gastric mucosa and the autonomous movement of the capsule in the gastrointestinal tract. After a series of explorations including air-producing powder, defoamer, protease preparation, patients are asked to drink about 800 ml-1000 ml water in a short time for standard gastric filling. However, the existing problems of gastric preparation such as abdominal distension, insufficient gastric filling, and long gastric retention time deserve attention. Different from the results of Zhu et al. (DLD, 2017), the current clinical experience shows that the addition of pronase granules in gastric preparation can often reduce the mucus in the stomach. But the standardized use of pronase granules remains to be further explored.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Changhai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese People's Liberation Army General Hospital after January 2020.
  3. Able to provide informed consent.

Exclusion Criteria:

  1. dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation;
  2. congestive heart failure, renal insufficiency, use of anticoagulant medication,
  3. implanted metallic devices such as pacemakers, defibrillators, artificial heart valves or joint prostheses (although the low magnetic field used technically should not interfere with such devices);
  4. pregnancy;
  5. currently participating in another clinical study.
  6. Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
  7. Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
  8. Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
  9. The patient's basic information in the database is incomplete#
  10. Patient fail to be followed up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Control group
All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of two liters of polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at the hospital in the morning after an overnight fast (>8hours). Then they would be randomly assigned to the control group or pronase group randomly. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg dimethicone. And 25 minutes before swallowing the capsule, the patient was asked to take 200ml warm water. There is still have 800-1000ml water for gastric filling 10 minutes before swallowing the capsule.
Drug: Deyou; Beijing Tide Pharmaceutical Co, China, containing 20,000 iu pronase granules combined with 1 g NaHCO3 to maintain the intragastric PH at 6-8
Drink Deyo with 200ml warm water 25 minutes before swallowing the capsule to remove mucus in the stomach.
EXPERIMENTAL: Pronase group
All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of two liters of polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at the hospital in the morning after an overnight fast (>8hours). Then they would be randomly assigned to the control group or pronase group randomly. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg dimethicone. And 25 minutes before swallowing the capsule, the patient was asked to take 20000 IU pronase Granules Combined with 1 g NaHCO3 dissolved in 200ml warm water to maintain the intragastric pH at 6 - 8. There is still have 800-1000ml water for gastric filling 10 minutes before swallowing the capsule.
Drug: Deyou; Beijing Tide Pharmaceutical Co, China, containing 20,000 iu pronase granules combined with 1 g NaHCO3 to maintain the intragastric PH at 6-8
Drink Deyo with 200ml warm water 25 minutes before swallowing the capsule to remove mucus in the stomach.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastric Cleanliness Score (GCS)
Time Frame: 2 weeks
Six primary anatomical landmarks of the stomach (cardia, fundus, body, angulus, antrum, and pylorus) were recorded for evaluation. A 4-point grading scale was introduced to define the cleanliness as excellent (no adherent mucus and foam: score 4), good (mild mucus and foam but do not obscure vision: score 3), fair (considerable amount of mucus or foam present precluding a completely reliable examination: score 2) and poor (large amount of mucus or foam residue needing water to clear it: score 1). GCS was the total scores of all six landmarks, ranging from 6 (completely unprepared) to 24 (perfect). GCS of≥18 was regarded as acceptable.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel
Time Frame: 2 weeks
Visualization of the small bowel was determined by the percentage of time during which the small-bowel view was clear, defined as not obscured more than 50% of the screen view. The clear-viewing percentage of the total small bowel transit time assessed by a 4-point scale :0, less than 25%; 1, 25% to 49%; 2, 50% to 75%; and 3, greater than 75%.
2 weeks
Fullness score
Time Frame: 2 weeks
Fullness is the subjective feeling of patients assessed with visual analogue scale (VAS). VAS typically take the form of a straight line with two extreme states anchored at either end. In this study, it is a 100mm VAS with a question"How full do you feel?"anchored with "not at all full"at the left side and "as full as I have ever felt" at the right side. Patients will be asked to mark their feelings on the line. The distance (mm) between the far left and the marked point is the score of fullness. 0 represents no perception at all, 10 indicates pain and needs to be stopped immediately.
2 weeks
Gastric Examination Time (GET)
Time Frame: 2 weeks
The time taken for the gastric examination to the endoscopist's satisfaction.
2 weeks
Esophageal transit time (ETT)
Time Frame: 2 weeks
The time between the first image of esophagus and the first image of stomach.
2 weeks
Gastric transit time (GTT)
Time Frame: 2 weeks
The time between the first image of stomach and the last image of stomach.
2 weeks
Small bowel transit time (SBTT)
Time Frame: 2 weeks
The time between the last image of stomach and the image of ileocecal valve.
2 weeks
Completion Rate (CR)
Time Frame: 2 weeks
The completion of stomach was defined as the observation of cardia, fundus, body, angulus, antrum and pylorus and the completion of small bowel examination was defined as the ileocecal valve was photographed.The completion rate in each group was defined as the percentage of patients with a complete examination out of the total number of patients examined.
2 weeks
Adverse events occurence rate
Time Frame: 2 weeks
The safety were evaluated at two week after procedure for any adverse events such as infection, pain, nausea, vomiting and capsule impaction or retention.
2 weeks
Detection rate of lesions
Time Frame: 2 weeks
The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gastric preparation of MCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings